Modeling Successful Phase 3 Trials
Pharmacometrics optimizes the use of Phase 2 data to support Phase 3 success.
Month: March 2016
Certara’s Synchrogenix Unit Provides Solution to Enable Pharma Compliance with EMA Policy 70
PRINCETON, NJ – Mar. 24, 2016 – Synchrogenix has introduced an artificial intelligence (AI) -enabled solution to meet the data transparency requirements of the clinical and drug development market.
Precision Dosing Using PBPK Modeling
Precision dosing― the right dose, for the right patient, at the right time― is crucial to providing patients with the most efficacious medications with minimal probability of adverse events. One key step towards achieving the delivery of individualized dosing is testing potential dosing regimens in a patient’s ‘virtual twin.’ The other key step is to … Continued
The Next Horizons in Predicting Drug-drug Interactions
Physiologically-based pharmacokinetic (PBPK) modeling has arrived in prime time. This quantitative mechanistic framework, combining physiology with drug information and clinical trial design, has become an integral part of drug discovery and development. PBPK has also gained currency within industry and regulatory agencies. Its applications are numerous, including simulation of pre-clinical, healthy volunteer and special population … Continued
What is Model-based Drug Development Worth?
If you have ever argued, as we have, for the resources and time needed for model-based drug development (MBDD), you have likely encountered that irritating accountant in the room who says, “Sure, this modeling stuff sounds interesting, but how much MONEY will this save us?” My answer: $97M of savings per New Drug Application (NDA). … Continued
Automated Prediction of First-in-man Dosing Using Pre-clinical PK Data
Humans differ from commonly used pre-clinical model organisms (rats, dogs, monkeys) in terms of their biochemistry, physiology, and anatomy. Predicting a drug’s pharmacokinetic (PK) profile in humans using animal PK data must account for these differences. Allometric scaling is used to predict human PK parameters based on animal data. While allometric scaling has been used … Continued
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3 pertains to quality data. It has become increasingly common for sponsors to reference a Drug Master File (DMF) within this module. A DMF contains detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs … Continued
How Modeling and Simulation Technology Impacted the “Class of ’15”
It’s been almost 20 years since the FDA approved a group of New Drug Applications (NDA) and Biologic License Applications (BLA) as large as the class of ’15. The 45 approved drugs represent a 10% increase over the prior year and an increase of 114% from the beginning of the decade. What accounts for this … Continued